03-07-19 USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

WASHINGTON, March 7, 2019 — The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) today announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.

FSIS and FDA released a formal agreement to address the regulatory oversight of human food produced using this new technology. The formal agreement describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce. This shared regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry are produced safely and are accurately labeled.

“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products,” said USDA Deputy Under Secretary for Food Safety Mindy Brashears. “We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labeling.”

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “Collaboration between USDA and FDA will allow us to draw upon the unique expertise of each agency in addressing the many important technical and regulatory considerations that can arise with the development of animal cell-cultured food products for human consumption.”

Under the formal agreement, the agencies agree upon a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to FSIS oversight will occur during the cell harvest stage. FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry.

On Oct. 23-24, 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The public meeting focused on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.

The FSIS, an agency within the U.S. Department of Agriculture, is the public health agency responsible for ensuring that nation’s meat, poultry, and egg products are safe, wholesome, and accurately labeled.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.